Log in or register to see all Alerts
New HTA Decisions in England
February 2020
Drug name
(sotagliflozin with insulin)
Company
Sanofi
Decision date
22/11/2019
Therapeutic area
Diabetes and other endocrinal, nutritional and metabolic conditions
Therapeutic sub area
Diabetes
Decision
Recommended with restrictions
Indication
Sotagliflozin with insulin is recommended as an option for treating type 1 diabetes in adults with a body mass index (BMI) of at least 27 kg/m² , when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.
Decision Detail
Sotagliflozin with insulin is recommended only if: • sotagliflozin is given as one 200 mg tablet daily; • they are on insulin doses of 0.5 units/kg of body weight/day or more and • they have completed a structured education programme that is evidence based, quality assured, delivered by trained educators and includes information about diabetic ketoacidosis, such as: • how to recognise its risk factors, signs and symptoms; • how and when to monitor blood ketone levels; • what actions to take for elevated blood ketones and • treatment is started and supervised by a consultant physician specialising in endocrinology and diabetes treatment, and haemoglobin A1c (HbA1c) levels are assessed after 6 months and regularly after this.
Summary
The main evidence for sotagliflozin came from two trials, inTandem1 and inTandem2, comparing sotagliflozin plus insulin therapy at 2 doses (200 mg or 400 mg) with placebo plus insulin therapy over 52 weeks. The committee noted that the improvement in HbA1c level in The Diabetes Control and Complications Trial (DCCT) and Epidemiology of Diabetes Interventions and Complications (EDIC) (for multiple daily injections of insulin compared with conventional glycaemic control) was substantially bigger (about a 2% [about 22 mmol/mol] reduction), and sustained for substantially longer (over 10 years) than the improvement in HbA1c level in the pooled inTandem trials (0.39% reduction [about 14 mmol/mol] over 1 year with sotagliflozin plus insulin compared with placebo plus insulin) in the preferred population. The committee concluded that it was reasonable to assume some relationship between lowering HbA1c and reducing diabetic complications, and an association between lowering BMI and improving quality of life. The committee recalled its conclusions that sotagliflozin with insulin modestly improved HbA1c and BMI, compared with insulin alone. It concluded that the most plausible ICER is between £15,163 per QALY gained and £25,115 per QALY gained. The committee concluded that sotagliflozin with insulin appears to be a cost-effective use of NHS resources for treating type 1 diabetes in adults with a BMI of 27 kg/m2 or more when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy. Sotagliflozin with insulin is therefore recommended as an option for type 1 diabetes in adults. Because of the increased risk of diabetic ketoacidosis, sotagliflozin should be stopped if blood glucose control does not improve.